Genentech, a member of the Roche Group, will develop and commercialize Hanmi Pharmaceutical’s Phase I cancer candidate HM95573 in most of the world, through a license agreement that could generate up to $910 million for the South Korean drug developer.

The exclusive development and license agreement gives Genentech worldwide rights, except in South Korea, to HM95573, a selective pan-rapidly accelerated fibrosarcoma (RAF) kinase inhibitor targeting solid tumors driven by the BRAF mutant and CRAF subtypes of RAF kinases.

According to Hanmi, HM95573 has shown potent antitumor activity in vitro and in vivo in BRAF, KRAS, and NRAS mutant models.

Genentech agreed to pay Hanmi $80 million upfront, plus up to $830 million in payments tied to achieving development, regulatory, and commercialization milestones. Hanmi is also eligible to receive from Genentech tiered double-digit royalties on products sales resulting from the license agreement.

Genentech is among biopharma giants that have partnered with Hanmi in recent months as the company has sought to reposition itself away from generics: “We will embark on an R&D strategy in which we gradually reduce the weight taken up by generics and come out as a company specializing in branded drugs,” Hanmi President Gwan-sun Lee told the Nikkei Asian Review in July.

Last year, Hanmi inked an up-to-$4.2 billion partnership through which Sanofi agreed to develop a portfolio of long-acting diabetes treatments using technology licensed from Hanmi.

The agreement is subject to customary closing conditions that include clearance under the Hart–Scott–Rodino Antitrust Improvements Act, which is expected to occur by year’s end.








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